Ambient vs. controlled test laboratory environment Test Method Evaluation Plan

M

mlthompson

#1
I am attempting to evaluate the effect of two different environments on test results (ambient vs controlled test lab environment). We want to determine if there will be a change is sample average and standard deviation. We make polyurethane foam seating product so the environment can effect the curing process and also the measurement repeatability of hardness results.

When developing the test plan for this study, how important is sample selection in performing the study? A couple of options we have is
  1. Pull 10 consecutive actual parts without concern on hardness variability within the sample. 5 parts would condition inside the controlled lab environment. The other 5 pieces would condition in the ambient envirnment.
  2. Pull samples using test blocks trying to assure that physical properties are as similiar as possible. 5 parts would condition inside the controlled lab environment. The other 5 pieces would condition in the ambient envirnment.

To me this is a mini DOE, where you need to minimize outside variation so the variation in the study results are isolated, as much as possible, to the two variables being evaluated. My concern is that using actual products introduces a certain amount of unknown variability that can negatively effect the study results. There are components that molded with the parts that could have its own independent effort on end results. To me, the sample parts going into the study needs to be as similiar as possible. Again the intent of the study is to evaluate the effect of two different variables (ambient vs test lab)

People on the other side of the debate doesn't feel that similiar physical properties are important to the study.

If I am wrong please correct me and offer how you would develop the test plan.

If I am right please describe how I can best convince folks on proper study preparation.
 
Elsmar Forum Sponsor

Jim Wynne

Staff member
Admin
#2
I am attempting to evaluate the effect of two different environments on test results (ambient vs controlled test lab environment). We want to determine if there will be a change is sample average and standard deviation. We make polyurethane foam seating product so the environment can effect the curing process and also the measurement repeatability of hardness results.

When developing the test plan for this study, how important is sample selection in performing the study? A couple of options we have is
  1. Pull 10 consecutive actual parts without concern on hardness variability within the sample. 5 parts would condition inside the controlled lab environment. The other 5 pieces would condition in the ambient envirnment.
  2. Pull samples using test blocks trying to assure that physical properties are as similiar as possible. 5 parts would condition inside the controlled lab environment. The other 5 pieces would condition in the ambient envirnment.
To me this is a mini DOE, where you need to minimize outside variation so the variation in the study results are isolated, as much as possible, to the two variables being evaluated. My concern is that using actual products introduces a certain amount of unknown variability that can negatively effect the study results. There are components that molded with the parts that could have its own independent effort on end results. To me, the sample parts going into the study needs to be as similiar as possible. Again the intent of the study is to evaluate the effect of two different variables (ambient vs test lab)

People on the other side of the debate doesn't feel that similiar physical properties are important to the study.

If I am wrong please correct me and offer how you would develop the test plan.

If I am right please describe how I can best convince folks on proper study preparation.
I think you'll need random sampling in order for your test results to be meaningful. If you control for physical properties, your samples might not be representative of "normal" production. Of course, if your null hypothesis is that there will be some results x for parts with physical properties y, then you need to control for physical properties. Perhaps you need to know more about your process variation wrt physical properties before testing, so that you can do non-random representative sampling. Otherwise, random sampling is best.
 
Thread starter Similar threads Forum Replies Date
C Ambient temperature_how we claim storage condition in label? Other Medical Device Related Standards 2
R NADCAP AC7108 - Tank Ambient Room Temperature Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
R Can maximum ambient operating temperature be specified higher than 40C? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
M Stability Testing of Medical Devices - Ambient Temperature and Long Term Storage 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
G Calibration laboratory start-up - Maintaining the same ambient conditions General Measurement Device and Calibration Topics 7
L Internal Calibration Laboratory Requirements - Ambient temperature, Humidity, Etc. Statistical Analysis Tools, Techniques and SPC 3
J Supplier Controlled Shipping (GM CS1) Condition Manufacturing and Related Processes 3
T Controlled Forms or documented requirements for records? ISO 13485:2016 - Medical Device Quality Management Systems 2
was named killer AS 9100D - Calibration Instructions - Controlled documents? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
B Do IFU designs have to be document controlled under ISO 13485? Document Control Systems, Procedures, Forms and Templates 2
C Certificate of Conformance Form - COC for each customer a controlled document? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
J Controlled information versus defined documents / records ISO 13485:2016 - Medical Device Quality Management Systems 3
D Controlled Environment requirements Miscellaneous Environmental Standards and EMS Related Discussions 1
C Work Instructions; Controlled/Uncontrolled? Document Control Systems, Procedures, Forms and Templates 5
I Dating controlled documents after changes - Revision History Document Control Systems, Procedures, Forms and Templates 13
qualprod Controlled sticker for product identification? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
Q Do Management Review records have to be on a controlled form? ISO 13485:2016 - Medical Device Quality Management Systems 30
S Controlled Document Location Document Control Systems, Procedures, Forms and Templates 3
GreatNate Document Control info - What is required on a controlled form/document for ISO 9001: 2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
G Defect codes and process codes need to be controlled AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
M How to calculate benefits? Moving some developed non controlled software/automation systems Service Industry Specific Topics 2
I R&D prototype documents need to be controlled? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K Work Order Form (Controlled Document)? Document Control Systems, Procedures, Forms and Templates 5
M Training template - controlled document? Document Control Systems, Procedures, Forms and Templates 21
D Controlled Documents & Note Making ISO 13485:2016 - Medical Device Quality Management Systems 4
P Controlled Setup Sheets for a production line Document Control Systems, Procedures, Forms and Templates 2
P Qualification of a Temperature Controlled Unit have to be empty? Qualification and Validation (including 21 CFR Part 11) 5
M ISO 14644 - Cleanrooms and associated controlled environments -Recovery Test Other ISO and International Standards and European Regulations 0
E Do all Controlled Document copies require a Stamp? Document Control Systems, Procedures, Forms and Templates 3
Uriel Alejandro Including "Internal Rules" as Controlled Documents in a QMS Document Control Systems, Procedures, Forms and Templates 7
J Employer Warning Notice a Controlled Document? Document Control Systems, Procedures, Forms and Templates 7
R How to Cross-Reference Controlled Documents Document Control Systems, Procedures, Forms and Templates 3
C Leveraging previous results in IQOQs - Environmentally Controlled Room 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R FAI (First Article Inspection) on source-controlled parts AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M Definition of a controlled document --> is a form a controlled document Document Control Systems, Procedures, Forms and Templates 14
P Employment Application Form - Controlled or Not? Document Control Systems, Procedures, Forms and Templates 3
L Specific Question about Printing Controlled Documents. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
T Controlled Forms - Centralized or Decentralized? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S CS2 (Controlled Shipping Level) by GM - CB notified. What about other customers? IATF 16949 - Automotive Quality Systems Standard 1
R Digital Storage of ITAR Controlled Documentation Other ISO and International Standards and European Regulations 7
N Do Material MSDS's Need To Be Controlled? Document Control Systems, Procedures, Forms and Templates 3
C Need examples for Controlled Shipping I and II (CSL) IATF 16949 - Automotive Quality Systems Standard 3
S Is a Dynamic Controlled Form acceptable per 21CFR820 Document Control Systems, Procedures, Forms and Templates 3
T Should a supplier self assessment form be a controlled document? Document Control Systems, Procedures, Forms and Templates 9
D Should Customer Drawings be controlled per AS9100 QMS ? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M Types of Controlled Documentation - Call Lists of Emergency Contacts Quality Manager and Management Related Issues 5
C Use of white-out or obliterating a portion of a controlled drawing or document Document Control Systems, Procedures, Forms and Templates 7
M Should spreadsheets be controlled? If so, how? Records and Data - Quality, Legal and Other Evidence 8
C Control of Records - Differences between Controlled Documents and Controlled Records Records and Data - Quality, Legal and Other Evidence 18
Q Modification in Controlled Documents AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4

Similar threads

Top Bottom